title: Efficacy of the HPV-16/18 AS04-adjuvanted vaccine against low-risk HPV types (PATRICIA randomized trial): an unexpected observation.
abstract: BACKGROUND
  Public Health England has reported a decrease of up to 20.8% in new diagnoses of external genital warts (GWs) among women aged <19 years since the national vaccination program with the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine began in 2008. A post hoc analysis of the phase III PATRICIA (PApilloma TRIal against Cancer In young Adults) trial (NCT00122681) was performed to ascertain whether protection against low-risk HPV types was apparent.
  
  
  METHODS
  Vaccine efficacy (VE) at 48 months was assessed against 6-month persistent infection (6MPI) with low-risk HPV types in the total vaccinated cohort (TVC) and in the TVC naive (for 25 HPV types tested) populations.
  
  
  RESULTS
  In the TVC naive cohort, VE against 6MPI (95% confidence interval) was 34.5% (11.3 to 51.8) for HPV-6/11, 34.9% (9.1 to 53.7) for HPV-6, 30.3% (-45.0 to 67.5) for HPV-11, and 49.5% (21.0 to 68.3) for HPV-74.
  
  
  CONCLUSIONS
  The HPV-16/18 AS04-adjuvanted vaccine appears to have moderate efficacy against persistent infections with a number of low-risk HPV types (HPV-6/11/74), which are responsible for the majority of external GWs, and recently, antibody and cell-mediated immune response to HPV-6/11 have been observed. These findings may help to explain the decrease in external GW diagnoses seen in England.
authors.affiliation: Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, United Kingdom.
authors.forename: Anne
authors.initials: A
authors.lastname: Szarewski
authors.forename: S Rachel
authors.initials: SR
authors.lastname: Skinner
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.forename: Barbara
authors.initials: B
authors.lastname: Romanowski
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: Dan
authors.initials: D
authors.lastname: Apter
authors.forename: Song-Nan
authors.initials: SN
authors.lastname: Chow
authors.forename: Jorma
authors.initials: J
authors.lastname: Paavonen
authors.forename: M Rowena
authors.initials: MR
authors.lastname: Del Rosario-Raymundo
authors.forename: Julio C
authors.initials: JC
authors.lastname: Teixeira
authors.forename: Newton S
authors.initials: NS
authors.lastname: De Carvalho
authors.forename: Maria
authors.initials: M
authors.lastname: Castro-Sanchez
authors.forename: Xavier
authors.initials: X
authors.lastname: Castellsagué
authors.forename: Willy A J
authors.initials: WA
authors.lastname: Poppe
authors.forename: Philippe
authors.initials: P
authors.lastname: De Sutter
authors.forename: Warner
authors.initials: W
authors.lastname: Huh
authors.forename: Archana
authors.initials: A
authors.lastname: Chatterjee
authors.forename: Wiebren A
authors.initials: WA
authors.lastname: Tjalma
authors.forename: Ronald T
authors.initials: RT
authors.lastname: Ackerman
authors.forename: Mark
authors.initials: M
authors.lastname: Martens
authors.forename: Kim A
authors.initials: KA
authors.lastname: Papp
authors.forename: Jose
authors.initials: J
authors.lastname: Bajo-Arenas
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.forename: Aureli
authors.initials: A
authors.lastname: Torné
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: David
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
authors.forename: Matti
authors.initials: M
authors.lastname: Lehtinen
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000536:Aluminum Hydroxide / Q000008:administration & dosage*; D017326:Clinical Trials, Phase III as Topic; D003218:Condylomata Acuminata / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D052163:Human papillomavirus 6 / Q000276:immunology; D006801:Humans; D015994:Incidence; D033162:Incidental Findings; D008050:Lipid A / Q000008:administration & dosage / Q000031:analogs & derivatives*; D015337:Multicenter Studies as Topic; D053918:Papillomavirus Vaccines; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014611:Vaccination
chemical_list: C532963:ASO4 mixture; D000276:Adjuvants, Immunologic; D008050:Lipid A; D053918:Papillomavirus Vaccines; D000536:Aluminum Hydroxide
keywords: HPV; HPV vaccine; genital warts; human papillomavirus